FDA Device · 2016
FDA Device recalls in 2016
RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.
- PS-500 Scope Warmer
FDA Device · Class II · 2016-02-10 · Josnoe Medical - INTEGRIS CV
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - INTEGRIS HM3000
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - ABX PENTRA Lactic Acid CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - INTEGRIS Allura 15-12 (mono)
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
FDA Device · Class II · 2016-02-03 · Fresenius Medical Care Renal Therapies Group - D-10 Rack Loader
FDA Device · Class II · 2016-02-03 · Bio Rad Laboratories - Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II…
FDA Device · Class II · 2016-02-03 · Midmark - Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue
FDA Device · Class II · 2016-02-03 · Globalmed Logistix - Fuse 1C Colonoscope
FDA Device · Class II · 2016-02-03 · Endochoice - Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
FDA Device · Class II · 2016-02-03 · Cook Medical - EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibo…
FDA Device · Class II · 2016-02-03 · Phadia Ab - arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484
FDA Device · Class I · 2016-01-27 · Arkray Factory Usa - FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades
FDA Device · Class II · 2016-01-27 · Depuy Mitek A Johnson And Johnson - Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for th…
FDA Device · Class II · 2016-01-27 · Mwt Materials - Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series
FDA Device · Class II · 2016-01-27 · Valeant Pharmacueticals International - GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000
FDA Device · Class II · 2016-01-27 · Ge Medical Systems - GE Healthcare, Aisys, 1011-9000-000
FDA Device · Class II · 2016-01-27 · Ge Medical Systems - Excella II Rod Cat
FDA Device · Class II · 2016-01-27 · Innovasis - Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part co…
FDA Device · Class II · 2016-01-27 · Mwt Materials - arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424
FDA Device · Class I · 2016-01-27 · Arkray Factory Usa - VNS Therapy AspireSR Generator Model 106
FDA Device · Class II · 2016-01-27 · Cyberonics - Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment
FDA Device · Class II · 2016-01-27 · Mwt Materials - Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical
FDA Device · Class I · 2016-01-27 · St Jude Medical Cardiac Rhythm Management Division - Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI enviro…
FDA Device · Class II · 2016-01-27 · Mwt Materials - Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic
FDA Device · Class I · 2016-01-27 · Brainlab Ag - Anesthesia device service kits
FDA Device · Class II · 2016-01-27 · Ge Medical Systems - Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part cover…
FDA Device · Class II · 2016-01-27 · Mwt Materials - TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of…
FDA Device · Class II · 2016-01-27 · Abeon Medical - Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part cov…
FDA Device · Class II · 2016-01-27 · Mwt Materials - Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-par…
FDA Device · Class II · 2016-01-27 · Mwt Materials - Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the M…
FDA Device · Class II · 2016-01-27 · Mwt Materials - TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure
FDA Device · Class II · 2016-01-27 · Abeon Medical - FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades
FDA Device · Class II · 2016-01-27 · Depuy Mitek A Johnson And Johnson - GE Healthcare, Aestiva MRI, 1006-9310-000
FDA Device · Class II · 2016-01-27 · Ge Medical Systems - Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
FDA Device · Class II · 2016-01-27 · Cyberonics - FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades
FDA Device · Class II · 2016-01-27 · Depuy Mitek A Johnson And Johnson - InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intr…
FDA Device · Class II · 2016-01-27 · Rymed Technologies - Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI envi…
FDA Device · Class II · 2016-01-27 · Mwt Materials - GE Healthcare, Aestiva 7900, 1006-9305-000
FDA Device · Class II · 2016-01-27 · Ge Medical Systems - Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment
FDA Device · Class II · 2016-01-27 · Mwt Materials - The e.cam Dual Signature Gamma Camera system
FDA Device · Class II · 2016-01-27 · Siemens Medical Solutions Usa - InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001
FDA Device · Class II · 2016-01-27 · Rymed Technologies - Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acq…
FDA Device · Class II · 2016-01-27 · Fukuda Denshi Usa - Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI enviro…
FDA Device · Class II · 2016-01-27 · Mwt Materials - IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
FDA Device · Class II · 2016-01-27 · Iba Dosimetry - GE Healthcare, Aisys CS2,1011-9050-000
FDA Device · Class II · 2016-01-27 · Ge Medical Systems - Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in t…
FDA Device · Class II · 2016-01-27 · Abeon Medical - Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma counter is intended to detect and count gamma radiati…
FDA Device · Class II · 2016-01-20 · Perkinelmer - FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent
FDA Device · Class III · 2016-01-20 · Becton Dickinson And Bd Biosciences - MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities
FDA Device · Class I · 2016-01-20 · Thornhill Research - UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilizatio…
FDA Device · Class II · 2016-01-20 · Orthopediatrics - RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation t…
FDA Device · Class II · 2016-01-20 · Brainlab Ag - Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal proc…
FDA Device · Class II · 2016-01-20 · Arthrocare - VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Softwa…
FDA Device · Class II · 2016-01-20 · Ortho Clinical Diagnostics - Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagno…
FDA Device · Class II · 2016-01-20 · Bayer Healthcare - Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing pu…
FDA Device · Class II · 2016-01-20 · Skytron Div The Kmw Group - RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation t…
FDA Device · Class II · 2016-01-20 · Brainlab Ag - VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System…
FDA Device · Class II · 2016-01-20 · Ortho Clinical Diagnostics - iChem 10 SG Urine Chemistry Strips, PN 800-7005
FDA Device · Class II · 2016-01-20 · Beckman Coulter - Perkin Elmer WIZARD2 1-detector,3", 1000 samples
FDA Device · Class II · 2016-01-20 · Perkinelmer - Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facil…
FDA Device · Class II · 2016-01-20 · Compview Medical - Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is intended to detect and count gamma radiati…
FDA Device · Class II · 2016-01-20 · Perkinelmer - MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilat…
FDA Device · Class I · 2016-01-20 · Thornhill Research - Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-2…
FDA Device · Class II · 2016-01-20 · Stryker Sustainability Solutions - Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of th…
FDA Device · Class II · 2016-01-20 · Zimmer Biomet - Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211
FDA Device · Class II · 2016-01-20 · Boston Scientific - 30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41
FDA Device · Class II · 2016-01-20 · Intuitive Surgical - Perkin Elmer WIZARD2 10-detector, 1000 samples
FDA Device · Class II · 2016-01-20 · Perkinelmer - Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker
FDA Device · Class II · 2016-01-20 · Boston Scientific - Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
FDA Device · Class II · 2016-01-20 · Biomet - Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100
FDA Device · Class II · 2016-01-20 · Perkinelmer - NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provid…
FDA Device · Class II · 2016-01-20 · Nipro Medical - Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit
FDA Device · Class II · 2016-01-20 · Mercury Enterprises - VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below
FDA Device · Class II · 2016-01-20 · Ortho Clinical Diagnostics - Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Loc…
FDA Device · Class II · 2016-01-20 · Zimmer Biomet - AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046
FDA Device · Class II · 2016-01-20 · Encore Medical - 0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41
FDA Device · Class II · 2016-01-20 · Intuitive Surgical - VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Softwa…
FDA Device · Class II · 2016-01-20 · Ortho Clinical Diagnostics - Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length
FDA Device · Class II · 2016-01-20 · Zimmer Biomet - Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050
FDA Device · Class II · 2016-01-20 · Perkinelmer - Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma counter is intended to detect and count g…
FDA Device · Class II · 2016-01-20 · Perkinelmer - Software version VD10E for Syngo X-Workplace
FDA Device · Class II · 2016-01-13 · Siemens Medical Solutions Usa - Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in co…
FDA Device · Class II · 2016-01-13 · Vidco - Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosph…
FDA Device · Class II · 2016-01-13 · Siemens Healthcare Diagnostics - ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee Brace is indicated for range of motion control at t…
FDA Device · Class II · 2016-01-13 · Corflex - CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance
FDA Device · Class II · 2016-01-13 · Partners In Medicine - Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients…
FDA Device · Class II · 2016-01-13 · Baxter Healthcare - Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. l…
FDA Device · Class II · 2016-01-13 · Otto Bock Healthcare - Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning soft…
FDA Device · Class II · 2016-01-13 · Elekta - Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CC…
FDA Device · Class II · 2016-01-13 · Siemens Healthcare Diagnostics - 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM
FDA Device · Class II · 2016-01-13 · 3m Health Care Business - Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to trans…
FDA Device · Class II · 2016-01-13 · Baxter Healthcare - ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace is indicated for range of motion control at the kn…
FDA Device · Class II · 2016-01-13 · Corflex - Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: For th…
FDA Device · Class II · 2016-01-13 · Baxter Healthcare - Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method…
FDA Device · Class II · 2016-01-13 · Siemens Healthcare Diagnostics - Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS anal…
FDA Device · Class II · 2016-01-13 · Siemens Healthcare Diagnostics - InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive ai…
FDA Device · Class II · 2016-01-13 · Ultradent Products - ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home car…
FDA Device · Class II · 2016-01-13 · Kci Usa - NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS S…
FDA Device · Class II · 2016-01-13 · Zimmer Manufacturing B V
Other years
2026 (2,088) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)